Course Description & Rational:

This course combines didactic coursework and hands-on training in sterile compounding and aseptic technique. The course is designed to educate and train pharmacists and technicians in current USP <797> standards, and includes instruction and training in the following areas or skills identified in USP <797> standards:

• Hand hygiene
• Garbing
• Cleaning and disinfection
• Calculations, measuring, and mixing
• Aseptic technique
• Achieving and maintaining sterility (and apyrogenicity if compounding with nonsterile components)
• Use of equipment
• Documentation of the compounding process (e.g., master formulation and compounding records)
• Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO Class 5 area
• Proper use of PECs
• Principles of movement of materials and personnel within the compounding area
• Hands-on training and competency assessments include: garbing, hand hygiene, hood cleaning, large and small volume parenteral preparations, controlled substances, pediatric preparations, parenteral nutrition (PN) compounding, and safe handling of hazardous CSPs

This is an ACPE accredited certificate program. This course meets the requirement for accredited training as defined by the Texas State Board of Pharmacy in TAC 291.133.

Course content is based on the pending September 2021 USP 797 Guidelines:

https://go.usp.org/Proposed_2021_Revisions_795_797 

Financial Disclosure Attestation Statement

I, Shannon Bui

disclose no vested interest in or affiliation with any healthcare organization or corporation offering financial support or grant monies for this continuing education activity, or an affiliation with an organization whose philosophy could potentially bias my presentation.

Textbook

Sterile Compounding and Aseptic Technique: Concepts, training, and Assessment for Pharmacy Technicians by Lisa McCartney ISBN 978-0-76384-083-9 (text & DVD)

Catalog Description

This course combines a two-day live workshop and process validations, along with pre-course reading, and significant online/distance learning (DIL) coursework, followed by two, proctored, written examinations, to train pharmacists and pharmacy technicians in sterile compounding and aseptic technique (SCAT). All course activities are designed to be completed within a two- month timeframe; however, motivated students may be able to move through the online coursework and written testing more quickly. The two-day, hands-on workshop is held in our state-of-the-art training facility in Austin, Texas. All other coursework is completed online using our Blackboard Learning Management System. This course requires significant preparatory work to be ready for the rigorous live workshop. The live workshop will be comprised of a brief review of USP<797>; standards and basic aseptic technique principles, followed by a series of process validation procedures which include aseptic garbing and hand washing, hood cleaning, large and small volume parenteral preparation, ampule preparation, etc. The total estimated time required to complete this course is 40 hours (live workshop combined with home-study); may be spread out over a period of from 2-weeks up to one- semester, depending on course section. This course is designed to train pharmacists and pharmacy technicians in basic sterile compounding and aseptic technique principles based on current USP<797> standards. CPE activity completers will receive a frame-able certificate of completion, ACPE statement of credit, and upload of ACPE credit of 4 CEUs (4.0 hours) into CPE monitor. This is a Practice-Based activity. NOTE: this course meets the requirements for accredited training defined by the Texas State Board of Pharmacy in TAC 291.133.

Prerequisites:

Certified (PTCB) pharmacy technician and/or registered pharmacy technician; or registered pharmacist or pharmacy intern; or be enrolled in or have completed an ASHP/ACPE-Accredited Pharmacy Technician Program or ACPE Accredited College of Pharmacy or have a minimum of six months of pharmacy experience. Preferred: ≥ two years of pharmacy experience and ≥ 6 months of direct sterile compounding experience. Note: Departmental approval is required via completion of the online petition.

Main Educational Objectives for Pharmacists

• Verify components and determine compatibility of compounded sterile preparations (CSPs)

• Perform and verify pharmaceutical calculations required in sterile compounding

• Demonstrate proficiency in garbing, hand hygiene, cleaning and disinfection of PEC, and various CSPs

• Assess current USP <797> standards, and apply to didactic and experiential coursework

Main Educational Objectives for Pharmacy Technicians

• Verify components and determine compatibility of compounded sterile preparations (CSPs)

• Perform and verify pharmaceutical calculations required in sterile compounding

• Demonstrate proficiency in garbing, hand hygiene, cleaning and disinfection of PEC, and various CSPs

• Assess current USP <797> standards, and apply to didactic and experiential coursework

Instruction Methodology

PHRA 1091 is a hybrid course with a laboratory (face-to-face) and an online (DIL) component.

Distance Education Information

Distance education classes are taught using Blackboard, the College-approved learning management system for online course delivery. Classes may use additional hardware and software, but the College-approved learning management system must serve as the gateway.

• Students use their unique ACCeID and password to securely login to Blackboard.

• Courses are available in Blackboard for students no later than the Friday before the session begins. For students who register after the session begins, it may take up to 24 hours for the course to appear in Blackboard.

• Course Confidentiality in Blackboard for Students - Only work submitted to open forums, like discussion boards, can be accessed by other students in the class. Assignments, grades, and correspondence are not viewable by other students.

• Professional Use Expectations for College Information Systems - The following statement appears on the Blackboard login page regarding the expectations and policies that all users must abide:
  “Users are expected to comply with ACC’s Administrative Rule on the Use of College Information Systems, and to be familiar with the Family Education Rights and Privacy Act (FERPA). Proceeding to use college information systems indicates your awareness of and commitment to comply with the above-referenced guidelines. If you are unsure of these guidelines or disagree with them, you are expected to exit now and consult with your supervisor or advisor.”

To earn ACPE Accredited CE in Sterile Compounding and Aseptic Technique (i.e. IV Certification) you must complete the following:

Submission of Required Paperwork: Student Registration Form Documentation of Training Hours Form Online Evaluation of CPE Activity

Midterm Exam - A score of 75% (or higher) is required to receive a passing grade

Midterm Lab Exam - A score of 75% (or higher) is required to receive a passing grade

Final Exam - A score of 75% (or higher) is required to receive a passing grade

Final Lab Exam - A score of 75% (or higher) is required to receive a passing grade

Competency Assessments (9) – 90% (or higher) compliance to basic aseptic technique principals

Homework Assignments A score of 85% (or higher)  is required to receive a passing grade

To earn ACPE Accredited CE in Sterile Compounding and Aseptic Technique (i.e. IV Certification) you must complete the following:

1. If you haven’t already done so, create your NABP ePID number.

Go to the NABP website at https://nabp.pharmacy/programs/cpe-monitor/

• Click on “Log In To CPE Monitor”
• Click on “Individual” or “Business” customers
• Click on “Create Login”

The statement of CE credit for this course will be provided via the CPE Monitor system. In order to receive proof of CE credit for the SCAT course, your students will need to provide us with their NABP ePID and their date of birth on the student information form. If you have any questions about creating the NABP ePID and e-Profile, please contact NABP customer service at 847-391-4406, or at nabp.pharmacy/help/

2. Fill out the Online Student Registration Form. Obtain the Online Student Registration Form and/or link from your instructor in Blackboard. You MUST fill the online form out completely. Also, please use proper grammar and punctuation. Your entry will be utilized to process your completion documentation. All fields are required for the CPE office to register you for your course and to also process your completion documents. You will not receive your ACPE CPE credits unless you have provided your NABP ePID number, and your date of birth. Upon completion of this online form, you will receive an email from Google Forms. Please retain this email for the duration of the course. If you need to make any additions/changes to your record, please use the link. Do not complete multiple forms to make changes.

ACTION REQUIRED:  Complete the ONLINE Student Registration Form using one of the links below. You will receive a confirmation email from ACC. Upload a PDF of the completed form or confirmation email to instructor by 11:59 PM Sunday, AUGUST 27th

PHRA Student Registration Form

https://bit.ly/2023StudentReg

3. Courses must be paid in full prior to the first day of the course. Please follow the directions provided by your instructor to register and pay for the course. See the ACC policy on reimbursement for withdrawal or for courses canceled due to low enrollment on the course announcement, located at http://www.austincc.edu.

4. Purchase the textbook.

ACC campus bookstore: click LINK:
Textbooks

You may also order the book from the Paradigm website at: https://www.paradigmeducation.com/product/sterile-compounding-and-aseptic-technique-second- edition.

Be sure to order a new textbook with Cirrus online (not a used copy), it is the only way that you will be able to access online resources and training videos that are a required component of this course. The textbook for this course is REQUIRED.

Textbook: Sterile Compounding and Aseptic Technique: Concepts, training, and Assessment for Pharmacy Technicians, 1st edition, by Lisa McCartney - Text with online resources via Cirrus

5. Track your coursework on the Documentation of Training Hours Form. Your instructor will provide you with the Documentation of Training Hours Form. Fill out the identifying information at the top of the form. As you progress through the course, fill in the number of minutes that you spend working on each chapter.

The Sterile Compounding and Aseptic Technique Course requires a minimum of 12 hours of didactic coursework, eight (8) hours of dedicated testing time, and a minimum of 20 hours of hands-on training for a total of 40 hours. Your Documentation of Training Hours Form should reflect a minimum of 40 hours of total training for the course. Your instructor must validate all of your training hours by signing off on your form and submitting it to the CPE provider at the end of the course. It is your responsibility to track your didactic hours and to submit your Documentation of Training Hours Form to your instructor for further completion at the end of the course. Submission of the Documentation of Training Hours Form is a requirement.

6. Complete the Didactic Portion of the Course. Complete all chapters of the textbook, including any reading, quizzes, or homework assigned by your instructor. Your instructor may assign additional readings, PowerPoint lecture materials, or other coursework to be completed on Blackboard or via another delivery method. In addition, you will be required to watch the training videos on the Cirrus online platform or as directed by your instructor. Refer to the course schedule provided by your instructor for course due dates.

7. Pass two (2) exams over didactic content and two (2) exams over lab content with a score of 75% or higher. The four exams cover information from your textbook, including the procedural labs from each chapter. Information will also be gleaned from laboratory activities and training, as well as directly from USP<797>.

8. Complete the required hands-on training in a pharmacy cleanroom, segregated compounding area (SCA), or IV lab. Your instructor will provide you with additional information regarding the mandatory training sessions.

9. Complete nine Competency Assessments. The competency assessment for each of the nine procedural labs must be completed under direct observation of your instructor, with 90% or higher compliance to basic aseptic technique principles as defined in USP<797>.

10. Return the Documentation of Training Hours Form to your instructor. The Documentation of Training Hours Form must be completed and returned to your instructor upon completion of the course. You must have tracked and determined that you have met the minimum of 12 hours of didactic training.

11. Complete the Online Evaluation of CPE Activity. Your instructor will provide you with the link for the Online Evaluation of CPE Activity; you must complete this online form. You will not receive your ACPE CPE credits otherwise.

Upon successful completion of this course, outlined in the steps above, your instructor will submit your exams, Competency Assessments, and Documentation of Training Hours Form to the CPE provider - Austin Community College, Pharmacy Technician Program for review. If all paperwork is complete and in order, the student will receive the following:

• A nationally recognized certificate in Sterile Compounding and Aseptic Technique from the Austin Community College – Pharmacy Technician Program – Provider of CPE ACPE accredited continuing education. The certificate will be emailed, within 30 days of receipt of final paperwork from the instructor. Completion documents will be sent to the student’s email address that was provided on the Online Student Registration Form.
• ACPE accredited continuing education units (CEUs) will be uploaded into CPE Monitor within 60 days of receipt of the final paperwork. ACPE credit will only be uploaded into CPE monitor if you provide your NABP ePID number and date of birth (month/day) on your Online Student Registration Form.

GRADING

DISTANCE LEARNING COURSE WITH LAB COMPONENT

LIVE LAB/Didactic Grade

Didactic Home Study Component (50% of Final Grade):

Homework Assignments in Blackboard (10% of final grade)

• FOURTEEN (14) Blackboard (Bb) assignments – Comprised of 14 blackboard assignments including chapter material, USP 797 September 2021 Update, A passing grade of 85% (or higher) is required to receive a passing grade.  For ACPE Total Parenteral Preparation Certification see requirements below

Exams: (40% of final grade)

Midterm Exam (Covering Chapters 1-7)

• 50 questions, multiple choice exam. A passing grade of 75% (or higher) is required to receive a passing grade

Midterm Lab Exam

• 50 questions, multiple choice exam. A passing grade of 75% (or higher) is required to receive a passing grade

Final Exam (Comprehensive covering Chapters 1-14)

• 50 questions, multiple choice exam. A passing grade of 75% (or higher) is required to receive a passing grade

Final Exam (Comprehensive covering Chapters 1-14)

• 50 questions, multiple choice exam. A passing grade of 75% (or higher) is required to receive a passing grade

LIVE Hands-on LAB Component (50% of Final Grade):

LIVE HANDS-ON LAB (50% of final grade)

Process Validations (9) – A passing grade of 90% (or higher) is required to receive a passing grade. For ACPE Sterile Compounding and Aseptic Technique Certification see requirements below.

Students will have an opportunity to repeat failed process validations (score <90%)

1. PV1 – Aseptic garbing, hand washing, and gloving
2. PV2 – Cleaning the horizontal PEC
3. PV3 – Large Volume Parenteral (LVP) Manipulation
4. PV4 – Small Volume Parenteral (SVP) Manipulation
5. PV5 – Ampule Based CSP Manipulation
6. PV6 – Narcotic PCA Preparation
7. PV7 – Pediatric Dilution Manipulation
8. PV8 – Total Parenteral Nutrition (TPN) Manipulation
9. PV9 – Chemotherapy/HD Manipulation

Course Grade 

This is how your course grade will be determined:

Monitor your progress

You can check your grades throughout the course by selecting the My Grades link in the menu.

I will provide feedback for each assignment one week after your submission.

Exams

Students must take four (4) exams and score 75% (or above) on each exam to meet the ACPE requirement. The exams will  be taken using Blackboard LockDown Browser.

Homework/Assignment Submission Guidelines

All assignments are required for the progression of the course. Homework/Assignments must be submitted to the instructor through Blackboard unless otherwise instructed. Homework/Assignments are due according to the course schedule in the syllabus.  The assignments must be submitted by 11:59 p.m. on due date.  Passing grade of 85% or above is required per homework assignment for ACPE Sterile Compounding and Aseptic Technique  Certification.  You will have the opportunity to retake an assignment up to 3 before or on the deadline.

Payment

Please contact ACC Registration

Cancellation Policy and Payment Information

Once payment to ACC has been completed, a total refund of tuition can only be made if ACC cancels the course or student drops the class before it begins. Partial refund of tuition may be available according to the ACC Refund Policy for students dropping courses. See Refund Policy at http://continue.austincc.edu/register .

ACC COLLEGE POLICIES 2023

Available to students in the College Policies & Student Support Services Tab once you log into Blackboard. See College Policies at https://www.austincc.edu/offices/academic-outcomes-assessment/master-syllabi/college-policies

Textbook

Sterile Compounding and Aseptic Technique: Concepts, training, and Assessment for Pharmacy Technicians by Lisa McCartney I

ACC campus bookstore: click LINK:
Textbooks

You may also order the book from the Paradigm website at: https://www.paradigmeducation.com/product/sterile-compounding-and-aseptic-technique-second- edition.

Be sure to order a new textbook with Cirrus online (not a used copy), it is the only way that you will be able to access online resources and training videos that are a required component of this course. The textbook for this course is REQUIRED.

Textbook: Sterile Compounding and Aseptic Technique: Concepts, training, and Assessment for Pharmacy Technicians, 1st edition, by Lisa McCartney - Text with online resources via Cirrus

Read September 2021 USP <797> Update:

• Proposed Revisions to <797> Pharmaceutical Compounding – Sterile Preparations
• Stability Study Reference Document for the 2021 Proposed Revisions to <795> and <797>
• BUD Scientific Rationale for the 2021 Proposed Revisions to <797>
• BUD Reference for the 2021 Proposed Revisions to <797>
• Compounding Expert Committee Responses to Stakeholder Engagement Themes for the 2021 Proposed Revisions to <797>

Watch USP <797 > September 2021 Video                                         

This course combines didactic coursework and hands-on training in sterile compounding and aseptic technique. The course is designed to educate and train pharmacists and technicians in current USP <797> standards, and includes instruction and training in the following areas or skills identified in USP <797> standards:

• Hand hygiene
• Garbing
• Cleaning and disinfection
• Calculations, measuring, and mixing
• Aseptic technique
• Achieving and maintaining sterility (and apyrogenicity if compounding with nonsterile components)
• Use of equipment
• Documentation of the compounding process (e.g., master formulation and compounding records)
• Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO Class 5 area
• Proper use of PECs
• Principles of movement of materials and personnel within the compounding area
• Hands-on training and competency assessments include: garbing, hand hygiene, hood cleaning, large and small volume parenteral preparations, controlled substances, pediatric preparations, parenteral nutrition (PN) compounding, and safe handling of hazardous CSPs

Student Technology Support

Austin Community College provides free, secure drive-up WiFi to students and employees in the parking lots of all campus locations. WiFi can be accessed seven days a week, 7 am to 11 pm. Additional details are available at https://www.austincc.edu/sts

Students who do not have the necessary technology to complete their ACC courses can request to borrow devices from Student Technology Services. Available devices include iPads, webcams, headsets, calculators, etc. Students must be registered for a credit course, Adult Education, or Continuing Education course to be eligible. For more information, including how to request a device, visit http://www.austincc.edu/sts

Student Technology Services offers phone, live-chat, and email-based technical support for students and can provide support on topics such as password resets, accessing or using Blackboard, access to technology, etc. To view hours of operation and ways to request support, visit http://www.austincc.edu/sts

COURSE RESOURCES

Course Blackboard Website:  https://acconline.austincc.edu/

You will use this website to access course material, submit assignments, take assessment quizzes, and take your exam. Make sure you check Blackboard regularly to meet course deadlines.  You are responsible for course information posted.

Textbook:  Sterile Compounding and Aseptic Technique: Concepts, training, and Assessment for Pharmacy Technicians by Lisa McCartney. ISBN 978-0-76384-083-9 (text & DVD)

Additional materials will be posted on Blackboard.  It is your responsibility to access these materials and bring copies of whatever will be needed in class when instructed to do so.

Technology Requirement

You will be required to access course materials and complete/submit assignments online for this course.  If you do not have access to a computer/laptop, please use the Learning labs available on ACC campus.  See Learning Lab campus locations: http://www.austincc.edu/support-and-services/tutoring-and-academic-help/learning-lab-services

You will also be required to upload documents in PDF format using such programs or apps as Evernote Scannable (you may download this app for free at: https://evernote.com/products/scannable).

COURSE EXPECTATIONS

Class Participation

This course can help you become a more strategic learner if you take responsibility for your own learning and engage the process. The instructor will determine this part of the grade based on your preparedness and participation in the course.  Using your aseptic technique skills and knowledge of performing a manual TPN CSP from Sterile Compounding and Aseptic Technique (SCAT), we will explore the use of the Automated BAXA TPN Compounder.  The virtual lab activities are designed to maximize the value of our time together and leverage the educational benefits of having a cohort of peer to learn alongside., so do yourself and your classmates a favor by coming prepared and contributing to the learning experience during the virtual discussions.

There are five components of success:

• Regular and timely class participation in discussions and completions of work is expected of all students.  If attendance or compliance with other course policies is unsatisfactory, the instructor may withdraw students from the class.
• Advanced reading and preparation of assigned materials - Review the TPN calculation lecture in Blackboard prior to the hands-on lab portion of the course. This will help hardwire your math skills required for TPN compounding in the adult, pediatric and pediatric populations during lab.  Complete the Practice TPN’s assigned in the Adult TPN and Pediatric Modules prior to lab.  I will set up a virtual time to meet to go over calculations. 
• Well-formed comments during lab discussions. Informed and well-formulated comments during lab discussions is and expectation.  USP Chapter <797> are minimum requirements in sterile injectable compounding.  We will discuss best practices during lab.  I won’t be able to address specific facility issues during lab. The time we have in lab is limited and extended discussions regarding interpretation of specific September 2021 USP Chapter <797> UPDATES may continue on our course blog.
• Mandatory attendance and punctuality for hands on lab component of the course - The hands-on lab process validations are designed to maximize the value of our time together and leverage the educational benefits of having a cohort of peers to learn alongside, so do yourself and your course participants a favor by coming prepared and contributing to the learning experience during lab.
• Professionalism.  Our lab sessions are a time and place for learning, where all students are expected to engage the learning process and not disrupt this opportunity for themselves or others.  Behaving respectfully toward everyone in the course means engaging in the learning activities at hand and refraining from doing anything not directly related to them (e.g., using cell phones/tablets/computers, carrying on side conversations, etc). See “Technical Standards and Essential Functions” below.

Lab hands-on component of the course – Mandatory LIVE 2-day hands on portion of the course

Inclement weather – emergency closure:  In cases of emergency where the Eastview Campus is closed on the scheduled lab dates, refer to the course announcements and check you email for updates.  It is your responsibility to communicate with me in an emergent closure situation.  You can text or call in cases of emergency to 512-779-6644.

Stay up-to-date

Unless otherwise stated, all assignments, class materials, supplemental resources, grades, email, and announcements will be posted on the course Blackboard site.  You are responsible for keeping up with information and communication via Blackboard.  There are TPN calculations you need to keep up with before we meet for the LIVE 2-day LAB. I recommend check Blackboard announcements daily.

Professional Code of Conduct 

Treat others with respect. Students will be held accountable for professional behavior during the course.  It is the student’s responsibility to communicate with the instructor throughout the duration of the course.  You may contact me through email and I will respond within 24- 48 hours.

Communicate with me

The best way to reach me is via email at shannon.bui@austincc.edu.  If you have questions or concerns about the course, need some help with a difficult concept or assignment, or anything else, I am always willing to listen and do what I can to help you.  Part of taking responsibility for your own learning in this course is staying in touch with me about any issues you may encounter that could affect your academic performance.  Don’t wait until it is too late to seek help! 

Some things to keep in mind:

• If you have a question that the whole class would benefit from, please ask during lab.
• If you have a personal question (e.g. regarding grades) that lends itself to an extended discussion, please see me during the lab lunch break or after lab concludes for the day. Also, you can make an appointment with me and I will send a link to a private virtual meeting room.

• Instructor E-mail Response Time: It is ACC policy for instructors to respond to a student's e-mail within 24 to 48 hours Monday through Friday during business hours. If a student e-mails an instructor in the off-hours or weekends, e-mails will be responded to the next business day.
• Email Etiquette: All emails between professor and student must be written in a professional manner.  In the subject line include the course description PHRA 2073/2373 and reason for email. (e.g., PHRA 2073/2373 Blackboard Assignment question). You should use a salutation (Professor Bui) and end with your full name.  Correct punctuation, capitalization, etc. must be used.  Email communication should not have texting shorthand.

Statement on Privacy

The Family Educational Rights and Privacy Act (FERPA) protects confidentiality of students’ educational records. Grades cannot be provided by faculty over the phone, by e-mail, or to a fellow student.

Recording Policy

To ensure compliance with the Family Education Rights and Privacy Act (FERPA), student recording of class lectures or other activities is generally prohibited without the explicit written permission of the instructor and notification of other students enrolled in the class section.  Exceptions are made for approved accommodations under the Americans with Disabilities Act. 

Recording of lectures and other class activities may be made by faculty to facilitate instruction, especially for classes taught remotely through Blackboard Collaborate or another platform.  Participation in such activities implies consent for the student to be recorded during the instructional activity.  Such recordings are intended for educational and academic purposes only.

Use of ACC email

All College e-mail communication to students will be sent solely to the student’s ACCmail account, with the expectation that such communications will be read in a timely fashion. ACC will send important information and will notify students of any college- related emergencies using this account. Students should only expect to receive email communication from their instructor using this account.  Likewise, students should use their ACCmail account when communicating with instructors and staff.  Information about ACC email accounts, including instructions for accessing it, are available at:  http://www.austincc.edu/help/accmail/questions-and-answers

Instructions for activating an ACC email account can be found at http://www.austincc.edu/accmail/index.php.

Course Requirements and Policies

Attendance/Class Participation

Attendance at both laboratory sessions in their entirety is mandatory. No exceptions.

Dress Code

The student will be expected to adhere to the dress code.  The dress code for the course is what a student would expect in an actual hospital environment.  During lab, students are required to wear medical scrubs and close-toed shoes (tennis shoes or similar are preferred). Medical scrubs are available at any medical uniform store. Please come dressed in scrubs and appropriate footwear for BOTH lab sessions.

 If you show up to lab in makeup, artificial nails, nail polish, without scrubs or open-toed footwear you will be asked to leave and you will be considered absent for that lab.

Main Educational Objectives for Pharmacists

• Verify components and determine compatibility of compounded sterile preparations (CSPs)

• Perform and verify pharmaceutical calculations required in sterile compounding

• Demonstrate proficiency in garbing, hand hygiene, cleaning and disinfection of PEC, and various CSPs

• Assess current USP <797> standards, and apply to didactic and experiential coursework

Main Educational Objectives for Pharmacy Technicians

• Verify components and determine compatibility of compounded sterile preparations (CSPs)

• Perform and verify pharmaceutical calculations required in sterile compounding

• Demonstrate proficiency in garbing, hand hygiene, cleaning and disinfection of PEC, and various CSPs

• Assess current USP <797> standards, and apply to didactic and experiential coursework

SCANS Competencies

1. SCANS Competencies

In 1990, the U.S. Department of Labor established the Secretary’s Commission on Achieving Necessary Skills (SCANS) to examine the demands of the workplace and whether our nation’s students are capable of meeting those demands. The Commission determined that today’s jobs generally require competencies in the following areas:

1. 1. Resources: Identifies, organizes, plans, and allocates resources
   2. Interpersonal: Works with others
   3. Information: Acquires and uses information
   4. Systems: Understands complex interrelationships
   5. Technology: Works with a variety of technologies

The Texas Higher Education Coordinating Board requires that all degree plans in institutions of higher education incorporate these competencies and identify to the student how these competencies are achieved in course objectives.

This course, Intravenous Admixtures and Sterile Compounding, incorporates the SCANS competencies in the following ways:

1. Resources
   • Manages time for completing assignments
2. Interpersonal
   • Demonstrates ability to effectively communicate with others on the medical team.
3. Information
   • Acquires and evaluates information presented in lectures
   • Organizes and maintains information required for passing examinations
4. Systems
   • Understands order of adding medications to a large volume parenteral.
   • Understands order of adding medications in a total parenteral nutrition order.
   • Understand relationship of pharmacy personnel with others on the medical team.
5. Technology
   • Acquires ability to properly prepare sterile pharmaceuticals.
6. Basic Skills
   • Demonstrates ability to work independently.
   • Demonstrates ability to learn through lecture, reading, class presentations, etc.
   • Demonstrates ability to function as a team member in a fast-paced medical environment.
7. Thinking Skills
   • Acquires the ability to solve pharmaceutical math problems.
   • Acquires the ability to prioritize workflow in sterile products room.
   • Acquires the ability to problem solve as related to duties in sterile products room.
8. Personal Qualities
   • Demonstrates responsibility through attendance
   • Demonstrates responsibility through assignment completion in a timely manner
   • Demonstrates self-management when completing assignments
   • Demonstrates integrity and honesty when completing assignments

Additional Information on ACC Pharmacy Program Accreditation & ACC Pharmacy Program Competencies

ASHP/ACPE ACCREDITATION STANDARDS FOR PHARMACY TECHNICIAN EDUCATION AND TRAINING PROGRAMS (JULY 10, 2018)

 2018 STANDARD CATEGORIES Based on the FIFTH EDITION of the MODEL CURRICULUM:

GOALS:

1. Personal/Interpersonal Knowledge and Skills
2. Foundational Professional Knowledge and Skills
3. Processing and Handling of Medications and Medication Orders
4. Patient Care, Quality and Safety Knowledge and Skills
5. Regulatory and Compliance Knowledge and Skills
6. Authority and Responsibility provided to Program Director
7. Strategic Plan
8. Advisory Committee  
9. Curricular Length
10. Curricular Composition and Delivery
11. Student Recruitment, Acceptance, Enrollment, and Representation
12. Faculty/Instructors
13. Documentation
14. Assessment of Competency Expectations
15. Assessments of Structure and Process

Standard 1:  Personal/Interpersonal Knowledge and Skills

ENTRY-LEVEL

1.   Demonstrate ethical conduct. PHRA 1091
2.   Present an image appropriate for the profession of pharmacy in appearance and behavior.   
3.   Demonstrate active and engaged listening skills. PHRA 1091
4.   Communicate clearly and effectively, both verbally and in writing.
5.   Demonstrate a respectful and professional attitude when interacting with diverse patient populations, colleagues, and professionals.
6.   Apply self-management skills, including time, stress, and change management.
7.   Apply interpersonal skills, including negotiation skills, conflict resolution, customer service, and teamwork.
8.   Demonstrate problem solving skills. PHRA 1091

ADVANCED-LEVEL

1. Demonstrate capability to manage or supervise pharmacy technicians in matters such as conflict resolution, teamwork, and customer service.
2. Apply critical thinking skills, creativity, and innovation. PHRA 1091
3. Apply supervisory skills related to human resource policies and procedures.
4. Demonstrate the ability to effectively and professionally communicate with other healthcare professionals, payors and other individuals necessary to serve the needs of patients and practice.

Standard 2:  Foundational Professional Knowledge and Skills

ENTRY-LEVEL

1. Explain the importance of maintaining competency through continuing education and continuing professional development.
2. Demonstrate ability to maintain confidentiality of patient information, and understand applicable state and federal laws.
3. Describe the pharmacy technician’s role, pharmacist’s role, and other occupations in the healthcare environment.
4. Describe wellness promotion and disease prevention concepts. 
5. Demonstrate basic knowledge of anatomy, physiology and pharmacology, and medical terminology relevant to the pharmacy technician’s role. 
6. Perform mathematical calculations essential to the duties of pharmacy technicians in a variety of settings.
7. Explain the pharmacy technician's role in the medication-use process.
8. Practice and adhere to effective infection control procedures.

ADVANCED-LEVEL

1.  Describe investigational drug process, medications being used in off-label indications, and emerging drug therapies. 
2.  Describe further knowledge and skills required for achieving advanced competencies.
3.  Support wellness promotion and disease prevention programs.  

Standard 3:  Processing and Handling of Medications and Medication Orders

ENTRY-LEVEL

1. Assist pharmacists in collecting, organizing, and recording demographic and clinical information for the Pharmacists’ Patient Care Process.
2. Receive, process, and prepare prescriptions/medication orders for completeness, accuracy, and authenticity to ensure safety.
3. Assist pharmacists in the identification of patients who desire/require counseling to optimize the use of medications, equipment, and devices.
4. Prepare patient-specific medications for distribution. PHRA 1091
5. Prepare non-patient-specific medications for distribution.
6. Assist pharmacists in preparing, storing, and distributing medication products including those requiring special handling and documentation.
7. Assist pharmacists in the monitoring of medication therapy. 
8. Maintain pharmacy facilities and equipment.
9. Use information from Safety Data Sheets (SDS), National Institute of Occupational Safety and Health (NIOSH) Hazardous Drug List, and the United States Pharmacopeia (USP) to identify, handle, dispense, and safely dispose of hazardous medications and materials. PHRA 1091
10. Describe Food and Drug Administration product tracking, tracing and handling requirements.
11. Apply quality assurance practices to pharmaceuticals, durable and non-durable medical equipment, devices, and supplies.
12. Explain procedures and communication channels to use in the event of a product recall or shortage, a medication error, or identification of another problem.
13. Use current technology to ensure the safety and accuracy of medication dispensing.
14. Collect payment for medications, pharmacy services, and devices.
15. Describe basic concepts related to preparation for sterile and non-sterile compounding. PHRA 1091
16. Prepare simple non-sterile medications per applicable USP chapters (e.g., reconstitution, basic ointments and creams).
17. Assist pharmacists in preparing medications requiring compounding of non-sterile products.
18. Explain accepted procedures in purchasing pharmaceuticals, devices, and supplies.
19. Explain accepted procedures in inventory control of medications, equipment, and devices.
20. Explain accepted procedures utilized in identifying and disposing of expired medications.
21. Explain accepted procedures in delivery and documentation of immunizations.
22. Prepare, store, and deliver medication products requiring special handling and documentation.

ADVANCED-LEVEL

Prepare compounded sterile preparations per applicable, current USP Chapters. PHRA 1091

Prepare medications requiring moderate and high level non-sterile compounding as defined by USP (e.g., suppositories, tablets, complex creams).

Prepare or simulate chemotherapy/hazardous drug preparations per applicable, current USP Chapters. PHRA 1091

Initiate, verify, and manage the adjudication of billing for complex and/or specialized pharmacy services and goods.

Apply accepted procedures in purchasing pharmaceuticals, devices, and supplies.

Apply accepted procedures in inventory control of medications, equipment, and devices.

Process, handle, and demonstrate administration techniques and document administration of immunizations and other injectable medications.

Apply the appropriate medication use process to investigational drugs, medications being used in off-label indications, and emerging drug therapies as required. 

Manage drug product inventory stored in equipment or devices used to ensure the safety and accuracy of medication dispensing.

Standard 4:  Patient Care, Quality and Safety Knowledge and Skills

ENTRY-LEVEL

1. Explain the Pharmacists’ Patient Care Process and describe the role of the pharmacy technician in the patient care process.
2. Apply patient- and medication-safety practices in aspects of the pharmacy technician's roles.
3. Explain how pharmacy technicians assist pharmacists in responding to emergent patient situations, safely and legally.
4. Explain basic safety and emergency preparedness procedures applicable to pharmacy services.
5. Assist pharmacist in the medication reconciliation process. 
6. Explain point of care testing.
7. Explain pharmacist and pharmacy technician roles in medication management services.
8. Describe best practices regarding quality assurance measures according to leading quality organizations.

ADVANCED-LEVEL

1. Verify measurements, preparation, and/or packaging of medications produced by other healthcare professionals.
2. Perform point-of-care testing to assist pharmacist in assessing patient's clinical status.
3. Participate in the operations of medication management services.
4. Participate in technical and operational activities to support the Pharmacists’ Patient Care Process as assigned.
5. Obtain certification as a Basic Life Support Healthcare Provider.

Standard 5:  Regulatory and Compliance Knowledge and Skills

ENTRY-LEVEL

1. Describe and apply state and federal laws pertaining to processing, handling and dispensing of medications including controlled substances.
2. Describe state and federal laws and regulations pertaining to pharmacy technicians.
3. Explain that differences exist between states regarding state regulations, pertaining to pharmacy technicians, and the processing, handling and dispensing of medications.
4. Describe the process and responsibilities required to obtain and maintain registration and/or licensure to work as a pharmacy technician.
5. Describe pharmacy compliance with professional standards and relevant legal, regulatory, formulary, contractual, and safety requirements.
6. Describe Occupational Safety and Health Administration (OSHA), National Institute of Occupational Safety and Health (NIOSH), and United States Pharmacopeia (USP) requirements for prevention and treatment of exposure to hazardous substances (e.g., risk assessment, personal protective equipment, eyewash, spill kit). PHRA 1091
7. Describe OSHA requirements for prevention and response to blood-borne pathogen exposure (e.g., accidental needle stick, post-exposure prophylaxis). 
8. Describe OSHA Hazard Communication Standard (i.e., “Employee Right to Know”). PHRA 1091

ADVANCED-LEVEL

1. Participate in pharmacy compliance with professional standards and relevant legal, regulatory, formulary, contractual, and safety requirements.
2. Describe major trends, issues, goals, and initiatives taking place in the pharmacy profession.